Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP)

Abstract

The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged >55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with >300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p = 0.39). In patients with low baseline OACA (<90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p < 0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.

Conflict of interest statement

A.S. reports research support from the American Heart Association. U.G., T.V., H.M., and J.L. are employees of Bayer A.G. M.J.T.S. is an employee of Huma Therapeutics Ltd. K.D.L. is an employee of Yuzu Labs PBC. K.W.M.’s financial disclosures can be viewed at http://med.stanford.edu/profiles/kenneth-mahaffey. M.P.T. reports receiving research support from Janssen Inc., American Heart Association, Bristol Myers Squibb, Bristol Myers Squibb- Pfizer Alliance, Bayer, Apple, Boehringer-Ingelheim, AstraZeneca, and the National Institutes of Health; reports data use agreements for research with Medtronic and iRhythm; has received consulting fees from Abbott, Cardiva Medical, Medtronic, Johnson & Johnson, and Biotronik; has unexercised equity options in AliveCor Inc; and is an Associate Editor for JAMA Cardiology, Co-Chair of the Heart Rhythm Society Digital Health Subcommittee, and on the Editorial Board of Cardiovascular Digital Health Journal. R.D. reports equity from HealthPals, Heartbeam, and iMedrix; and consulting with Bayer and AstraZeneca. The remaining authors declare no competing interests.

© 2022. The Author(s).

Figures

Fig. 1. DeTAP recruitment and enrollment flow.

Participants were recruited through both traditional and social media methods. This figure outlines the flow of participant recruitment and enrollment.

Fig. 2. DeTAP trial recruitment volumes over time with traditional and virtual, social media-based recruitment.

IRB Institutional Review Board, FB facebook, SMS short message service (text messaging service), VoIP Voice over internet protocol (Figure provided by StudyPages, Yuzu Labs PBC).

Fig. 3. DeTAP study protocol flow.

SCCR Stanford Center for Clinical Research, OAC oral anticoagulant, EKG electrocardiogram, BP blood pressure, HR heart rate, DeTAP decentralized trial in afib patients, App smartphone/mobile application, AF atrial fibrillation, AEs adverse events.